Prospective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results

NCT05951075 | Recruiting

• 1 other identifier: BirdandBe
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

Male factor infertility is a leading cause of primary and secondary infertility. Poor sperm quality is defined as having an abnormal semen analysis. There are now options to assess sperm quality with at-home sperm analysis kits, including an FDA approved Yo Sperm kit (https://yospermtest.com/) which analyzes the motile sperm concentration \[concentration (millions / ml) x motility (Percentage motile)\] and sperm quality (YO Score) which compares your results to laboratory standards and to other men who have fathered children. The effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated. Taking additional supplements to improve sperm quality represent a modifiable risk-factor that would be an easy intervention for patients struggling with male factor infertility. The life cycle of sperm production is estimated at 3 months, so any intervention would require a 3 month course to see its full effect. The investigators hypothesize that a 90 day course of the "Power Prenatal for Sperm", a male fertility supplement by Bird\&Be (https://birdandbe.com/the-power-prenatal-for-sperm) will improve sperm quality (YO Score) after taking the supplements.

Conditions

Spermatogenesis and Semen Disorders; Infertility, Male

Outcome Measures

Primary Outcomes (1)

• YO Sperm Score

  At-home YO Sperm score (10-90) YO Score is a ranking of a participants motile sperm concentration (MSC) compared to other men who have fathered children. The result is 10 to 90 in intervals of 10. A score of10 represents the lowest score (participant ranks above 10% of fathers), and 90 the highest score (participant ranks above 90% of fathers). The higher your YO Score, the more likely you are to achieve a pregnancy in a shorter amount of time. YO Score is a reliable tool for monitoring MSC changes over time

  The YO Scores will be compared between baseline (prior to intervention) and after 3 months

Study Arms (1)

Power Prenatal for Sperm

EXPERIMENTAL

This is a single arm study. Participants will take supplements for 4 months. The supplements is Power Prenatal for Sperm (active ingredients - https://birdandbe.com/the-power-prenatal-for-sperm)

Dietary Supplement: Power Prenatal for Sperm

Interventions

Power Prenatal for Sperm DIETARY_SUPPLEMENT

A prenatal vitamin complex that includes numerous ingredients aim at improving sperm quality (ingredients: https://birdandbe.com/the-power-prenatal-for-sperm

Also known as: Prenatal Vitamin

Power Prenatal for Sperm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Focus on sperm quality
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male patients with at-home YO Sperm score between 20-40, corresponding to a MSC (motile sperm concentration) between 14-39 motile million / ml
• Ages 18-50
• Living in USA or Canada

You may not qualify if:

• Active smokers
• A known cause of male infertility (eg diagnosed varicocele, hormonal issue, history of testicular surgery, history of chemotherapy, etc)
• Not concurrently taking other forms of prenatal vitamins

Sponsors & Collaborators

• The Bird and Be Co Inc: lead

Study Sites (1)

Medical Electronic Systems

Encino, California, 91390, United States

RECRUITING

Related Publications (1)

• Salas-Huetos A, Rosique-Esteban N, Becerra-Tomas N, Vizmanos B, Bullo M, Salas-Salvado J. The Effect of Nutrients and Dietary Supplements on Sperm Quality Parameters: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Adv Nutr. 2018 Nov 1;9(6):833-848. doi: 10.1093/advances/nmy057.

  PMID: 30462179 BACKGROUND

Related Links

• WHO laboratory manual for the examination and processing of human semen

MeSH Terms

Conditions

Infertility, Male

Interventions

Sperm Count; Prenatal Care

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Semen Analysis; Investigative Techniques; Cell Physiological Phenomena; Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dan Nayot, BSc, MSc, MD

  The Bird and Be Co Inc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Nayot, BSc, MSc, MD

CONTACT

14166163334; dan@birdandbe.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Male patients that used the FDA approved YO Sperm at-home sperm analysis kit, and were identified with low YO Score results (20-40) will be recruited to take a 3 month course of supplements (Power Prenatal for Sperm), and a monthly YO Score at-home sperm test will be performed monthly for 3 consecutive months after starting the supplements.

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 18, 2023
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)